Federal prosecutors just brought criminal and civil charges against more than 100 makers or marketers of bogus dietary supplements. Businesses and individuals in 18 states across the US were targeted.
That's the outcome of a year-long investigation into the supplement industry, a probe that involved the Department of Justice, the Food and Drug Administration, the IRS, the Federal Trade Commission, and the Department of Defense, among others.
Two companies in particular, USPlabs and SK Laboratories, face criminal charges for allegedly lying about the ingredients in their products. Four executives from these companies were arrested on Tuesday, and two are expected to surrender, according to the Justice Department.
"Almost every day, news sources on the internet, television, and in print feature stories about the dangers of dietary supplements," said Benjamin Mizer, head of the Justice Department’s civil division. He was alluding to reports that "botanical" pills sold in stores are sometimes laced with dangerous pharmaceuticals and untested chemicals, and that supplements have been linked to at least 2,000 hospitalizations each year.
In each of the 117 cases, federal agencies allege that companies were selling either dietary supplements that contained ingredients other than what was listed on the label or products that made claims that weren't supported by scientific evidence.
One company sold mislabeled supplements without testing
One of the criminal indictments involves Dallas-based USPlabs, the maker of the popular workout and weight loss supplement OxyElite Pro.
The indictment alleges that USPlabs "engaged in a conspiracy to import ingredients from China using false certificates of analysis and false labeling and then lied about the source and nature of those ingredients after it put them in its products." It also claims that USPlabs withheld that information from retailers and marketed their products as "natural."
Before USPLabs agreed to pull OxyElite Pro from store shelves, the product sickened dozens of people, leading to acute liver failure, hepatitis, liver transplants, and, in at least one case, death. Meanwhile, instead of actually discontinuing distribution of the product, the Department of Justice says the company "engaged in a surreptitious, all-hands-on-deck effort to sell as much OxyElite Pro as it could as quickly as possible."
USPlabs also allegedly knew about the potential for liver toxicity. But the company didn't properly test its products. In a weird twist, people who worked at the company are accused of simply testing products on themselves and then selling "the ones that made them feel good," Mizer said.
There's very little oversight of supplements
Government actions like this tend to be a rarity, since there's little regulation of supplements. Approximately half of Americans report using dietary supplements — from herbals that promise to help with weight loss to vitamins and minerals — with the hopes of improving their health. Supplements are now the most common form of alternative medicine, and spending on them tops $30 billion every year.
Yet these pills undergo limited scrutiny by regulators. The FDA treats them like food — not like drugs — under the Dietary Supplement Health and Education Act of 1994. Supplement manufacturers can put a wide variety of claims on their bottles, so long as there's at least some research to back them up and so long as they're honest about their ingredients. There's no requirement for manufacturers to specify the quantity ingredients or to warn consumers about potential side effects. What's more, there are no regulators checking to make sure these manufacturers are telling the truth about what's in their products before they hit store shelves.
To remove a supplement from the market, the FDA first has to prove that it's not safe — which is what happened in the case of OxyElite Pro. This is basically the opposite of how pharmaceuticals are regulated. There, drugmakers need to prove their medicines are safe and effective through high-quality scientific studies before they ever reach consumers.
The feds are sending a signal to makers of supplements and to consumers
Dietary supplement researcher Pieter Cohen said the move should send a strong message to consumers and the industry. "Usually in the past, criminal charges have involved relatively small operations," he said. "But here the Justice Department is going after the makers of supplements and company leaders that right now sell products in every state. And they're going after people individually instead of trying to shut down the company.
"The Justice Department is saying, 'Enough is enough. We recognize this a serious public health threat, and that there's illegal activity in the supplement industry.' They're making a strong statement that you cannot place consumers at risk while you blatantly ignore the law."
The Council for Responsible Nutrition, the leading trade association representing the dietary supplement and functional food industry, said it was grateful to the government "for taking an important step today toward protecting consumers and responsible dietary supplement companies by taking strong enforcement actions against companies that do not follow the laws and put consumers at risk."